Europe: Updated EMA Guidance on Paediatric Submissions via eSubmission Gateway and Web Client

Following the release of revision 4 of the EMA guidance on paediatric submissions on 13 July 2021, the key changes are as follows:

• From 10 October 2021 a Research Product Identifier (RPI) will be required for paediatric procedures and, contrary to previous guidelines, will now be a mandatory field in the electronic application form for Paediatric Investigation Plans (PIPs), modifications of agreed PIPs and requests for waivers.

• Submission of more than one Submission-Unit in a single submission is possible if it is for the same procedure e.g. if one is submitting a validation response and wishes to notify the EMA of a contact change at the same time, then “validation response” as the submission unit from the table must be selected

Reference document: click here